Sedipanto 20 mg - antacid medicament 14 tablets

Product Description

Medicine for the short-term treatment of reflux disease

Indications

Sedipanto is indicated for the short-term treatment of reflux symptoms (e.g. heartburn, gastric regurgitation) in adults.

Composition

Active substances

Each gastro-resistant tablet contains 20 mg pantoprazole as pantoprazole sodium sesquihydrate.Excipient with known effect: - sorbitol (E420): 18 mg/tablet For the full list of excipients, see section 6.1.

Excipients

Tablet core: Mannitol; crospovidone (type B); sodium carbonate anhydrous; sorbitol (E420); calcium stearate.Film coating: Hypromellose; povidone; titanium dioxide (E 171); yellow iron oxide (E 172); propylene glycol; methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%; sodium lauryl sulfate; polysorbate 80; macrogol 6000; talc.

Directions for use and Dosage

The recommended dose is 20 mg pantoprazole (one tablet) daily. To achieve symptomatic relief, it may be necessary to take the tablets for 2-3 consecutive days. Once complete relief of symptoms has occurred, treatment may be discontinued. Treatment should not exceed 4 weeks without consulting a doctor. If symptomatic relief is not achieved within 2 weeks of continued treatment, the patient should be advised to consult their doctor.

No dose adjustment is necessary in elderly patients or in patients with impaired renal or hepatic function. Paediatric population: The use of Sedipanto is not recommended in children and adolescents under 18 years of age due to insufficient data on safety and efficacy.

Sedipanto 20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with some water before a meal.

Pregnancy and breastfeeding

Pregnancy: There are no adequate data from the use of pantoprazole in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Sedipanto should not be used during pregnancy unless clearly necessary.

Breastfeeding: Animal studies have shown excretion of pantoprazole in breast milk. Excretion into human milk has been reported. Therefore, a decision on whether to continue/discontinue breastfeeding or to continue/discontinue therapy with Sedipanto should be made taking into account the benefit of breastfeeding for the child and the benefit of Sedipanto therapy for the mother.

Fertility: Studies have shown no effect of pantoprazole on the fertility of male or female rats.

Format

14 gastro-resistant tablets